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临床试验/CTRI/2025/11/097938
CTRI/2025/11/097938尚未招募不适用

Comparision Of Heamodynamic Profile Of I-Gel and Proseal LMA In Laparoscopic Cholecystectomy

Dr SUDHEEKSHA S1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
comparision of heamodynamic profile of Igel and proseal lma in laparoscopic cholecystectomy

研究概览

简要总结

Second generation supraglottic devices  such as proseal lma and igel have replaced the  classical laryngeal mask airway as they form more effective seal and has a port that facilitates the suction of gastric contents and prevent gastric insufflation and regurgitation.

Even though endotrachial intubation is gold standard method in laparoscopic surgeries recently designed LMAs secure the airway with fewer complications and lesser hemodynamic changes as a substitute to endotracheal intubation.

In this study we are comapring the heamodynamic changes between proseal lma and igel insertion .

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • BMI 18- 25 kg/m2 ASA grade 1 and 2.

排除标准

  • Patient refusal Patients with a high risk of aspiration including hiatus hernia and pregnancy and GERD.
  • Anticipated difficult airway and pathology of neck and upper respiratory tract and mouth opening less than 2.5 cm.
  • Procedures requiring preoperative nasogastric tube placement and nasal and oral airway Duration of surgery that exceeds 90 minutes Chronic discases such as uncontrolled hypertension and uncontrolled diabetes mellitus and bronchitis and bronchial asthma.

结局指标

主要结局

comparision of heamodynamic profile of Igel and proseal lma in laparoscopic cholecystectomy

时间窗: T(0) - before induction | T(1) - just before insertion | T(2) - just after insertion | T(3) - 1min | T(4) - 3min | T(5) - 5min | T(6) - after carboperitonium | T(7) - 15min | T(8) - 30min | T(9) - 45min | T(10) - 60min | T(11)- 90min | T(12) - immediately after removal | T(13) - 5min after removal

次要结局

  • comparision of airway parameters(T(0) - at the time os insertion)

研究者

发起方
Dr SUDHEEKSHA S
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr SUDHEEKSHA S

Shimoga Institute Of Medical Sciences Shimoga

研究点 (1)

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